Test 4 Students in Research

Question 1

What is the Nuremberg Code and what is its major premise?

Answer 1

The Nuremberg Code was developed following the Nuremberg Military Tribunal, which judged human experimentation conducted by the Nazis. The Code encompasses many of the basic principles governing the ethical conduct of human subjects research today. The Nuremberg Code states that “the voluntary consent of the human subject is absolutely essential”

Question 2

What were the major contributions of the Declaration of Helsinki?

Answer 2

Research with humans should be based on the results from laboratory and animal experimentation
Research protocols should be reviewed by an independent committee prior to initiation
Informed consent from research participants is necessary
Research should be conducted by medically/scientifically qualified individuals
Risks should not exceed benefits

Question 3

What is the Common Rule?

Answer 3

provides for the basic foundation of the Institutional Review Boards. This Federal Policy has been codified by the federal agencies that conduct, support, or otherwise regulate human subjects research, hence the title “Common Rule.”

Question 4

What are the 3 principles outlined in the Belmont Report?

Answer 4

Respect for Persons
Beneficence
Justice

Question 5

What are the requirements for IRB composition?

Answer 5

The IRB must be diverse and must include at least one member whose primary concern is in a scientific area and one who is not a scientist.

Question 6

What is the responsibility of the IRB?

Answer 6

reviewing all projects involving human subjects for compliance with institutional policies and state, local, and federal laws, as well as the ethical principles contained in the Belmont Report (that is, respect for persons, beneficence, and justice).

Question 7

What is exempt review?

Answer 7

research with human subjects that generally involves no more than minimal risk.

Question 8

What are the requirements for a research project to be exempt?

Answer 8

minimal risk

Question 9

What is an expedited review?

Answer 9

minimal risk

Question 10

What are the requirements for a research project to be considered for an expedited review?

Answer 10

minimal risk

Question 11

Who conducts an expedited review?

Answer 11

The chair or designated experienced reviewer

Question 12

What is the definition of “research”

Answer 12

a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge

Question 13

What is the definition of a “human subject”?

Answer 13

a living individual ABOUT whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Question 14

What is meant by nonengagement in research?

Answer 14

institution’s employees or agents act as consultants on research but at no time obtain, receive, or possess identifiable private information, perform commercial services for the investigators, or inform prospective subjects about the availability of research.

Question 15

Who completes the IRB application?

Answer 15

Student under guidance from faculty advisor

Question 16

What are the 4 IRB review outcomes?

Answer 16

Approval
Approval with contingencies/stipulations
Deferred
Non-approval

Question 17

When do you recruit subjects?

Answer 17

Once the application is approved

Question 18

When can you implement modifications to your research proposal?

Answer 18

after they are reviewed and approved by the IRB

Question 19

What is an adverse event?

Answer 19

undue harm

Question 20

What are the reporting requirements for the researcher?

Answer 20

Prior to the expiration of a study, the IRB will require submission of a status report to assess the study’s progress or a final report when the study is completed. Either the student or the faculty advisor may submit the final report.

Question 21

What is PHI?

Answer 21

protected health information

Question 22

What are the general guidelines for writing an informed consent document?

Answer 22

clearly written and understandable to subjects. The language must be non-technical

Question 23

What are the specific requirements for informed consent?

Answer 23

Purpose of the research
Procedures involved in the research
Alternatives available should a subject decide not to participate in the research
All foreseeable risks and discomforts to the subject. *Note that these include not only physical injury but also possible psychological, social, or economic harm, discomfort, or inconvenience.
Benefits of the research to society and possibly to the individual human subject
Length of time the subject is expected to participate
Payment for participation (if applicable)
Person to contact for answers to questions or in the event of a research-related injury or emergency
Statement that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the person is otherwise entitled to receive
Subjects’ right to confidentiality and right to withdraw from the study at any time without any consequence

Question 24

What is consent and what is assent?

Answer 24

consent = over 18 assent is agreement for under 18

Question 25

What is privacy?

Answer 25

having control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.

Question 26

What is confidentiality?

Answer 26

treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.

Question 27

What is a risk?

Answer 27

Risk is the probability of harm or injury (physical, psychological, social, or economic) occurring as the result of participation in a research study.

Question 28

What is meant by benefit?

Answer 28

direct benefit to client (not vague benefit to society)

Question 29

What are primary and secondary sources of data?

Answer 29

Primary data collection involves direct contact with, or observation of, one or more people for the purpose of collecting data about them
Secondary data collection involves accessing information that has already been obtained about humans, either individually or in aggregate form.

Question 30

What is deception?

Answer 30

intentional misleading of subjects or the withholding of full information about the nature of the study.

Question 31

What is meant by vulnerable populations?

Answer 31

People who cannot competently understand the information regarding a study

Question 32

What considerations are necessary to involve students in research projects?

Answer 32

they have other gains?

Question 33

What are the responsibilities of faculty members?

Answer 33

supervize